CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 471 enrolled
Drug / intervention
QGE031 +2 moredrug
Likely dose
QGE031 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01716754
NCT01716754Phase 2Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

Novartis Pharmaceuticals·interventional·Posted Oct 30, 2012·Updated Aug 11, 2017

In Brief

A Phase 2 clinical trial evaluating QGE031, Omalizumab, and 1 other intervention for Asthma. Completed, enrolled 471 participants across 150 sites in 24 countries.

Detailed Summary

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Czechia, Finland, France, Germany, Guatemala, Hungary, India, Israel, Italy, Mexico, Panama, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2012
Enrollment StartDec 1, 2012
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.7 years ago

Interventions

QGE031drug

QGE031 was supplied as 120 mg liquid in vial per 1 mL

Omalizumabdrug

Omalizumab was supplied as 150 mg lyophilisate in vial

Placebodrug

Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL